AKANTIOR 0.8 mg/mL eye drops, solution in single-dose container

AKANTIOR contains the active substance polihexanide.

AKANTIOR is used in adults and children from 12 years of age to treat Acanthamoeba keratitis, Acanthamoeba is a parasite (tiny organism that lives inside humans and can cause disease) which can cause an infection resulting in keratitis (inflammation of the cornea, the clear layer in front of the eye). Acanthamoeba keratitis can cause severe defects on the surface of the cornea, including ulcers (open sores).

AKANTIOR damages the membrane (outer skin) of the Acanthamoeba parasite resulting in leakage of the cellular contents which destroys the cell. AKANTIOR also prevents the Acanthamoeba parasite from making copies of its DNA by interfering with enzymes (proteins) responsible for the replication process, which stops the growth and reproduction of the parasite in humans.

Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.

The treatment consists of two parts:
intensive treatment that lasts for the first 19 days and continuation treatment that lasts from day 20.
The recommended dose is 1 drop of AKANTIOR in the affected eye as follows:

Starting intensive treatment (19 days)

• Apply one drop every hour (16 times a day), for the first five days (days 1 to 5)
• Apply one drop every 2 hours (8 times a day), for a further seven days (days 6 to 12)
• Apply one drop every 3 hours (6 times a day), for a further seven days (days 13 to 19)

Continuation treatment

• Apply one drop every 4 hours (4 times a day), until there is no corneal inflammation or no evidence of infection (cured)
  Your doctor will advise you when to stop treatment.

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The majority of side effects generally occur at the treated eye.
Contact your doctor if you have a severe eye reaction.

The following side effects have been reported:
Very common (may affect more than 1 in 10 people)

• eye pain
• ocular hyperaemia (eye redness)

Common (may affect up to 1 in 10 people)

• corneal perforation (damage to the corneal surface)
• visual impairment
• ulcerative keratitis (inflammation or infection of the cornea)
• corneal epithelium defects (defects of outermost corneal layer)
• corneal infiltrates (immune response to corneal insult)
• punctuate keratitis (small breaks in the surface of the eye)
• tearing (watery eyes)
• conjunctival hyperaemia (redness of the conjunctiva)
• eye inflammation
• eye irritation
• photophobia (unpleasant eye sensitivity to light)
• conjunctival papillae (inside of eyelid gets red, swollen and irritated)
• eye pruritus (itchy eyes)
• eye discharge
• eye swelling
• foreign body sensation in the eye
• discomfort in the eye
• dry eye
• conjunctivitis (inflammation of the outermost layer of the eye)
• eye infection
• condition aggravated (disease worsening)
• product intolerance (hypersensitivity to the medicine)
• application site reactions such as pain
• application site reactions such as discomfort
• application site reactions such as pruritus (itching)
• persistent epithelial defect (persistent loss of outermost corneal layer after injury)
• toxicity to various agents
• corneal transplant required

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date refers to the last day of that month of the unopened product.

This medicine does not require any special storage conditions.

After opening the sachet, the single-dose containers have to be used within 28 days.
After this period, the unused single-dose containers must be discarded.

The contents of the single dose container must be used immediately after opening and any remaining content should be discarded.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away any medicines you no longer use.
These measures will help protect the environment.